Company Overview - Capricor Therapeutics (CAPR) shares increased by 5.3% to close at $6.52, with trading volume significantly higher than usual, contrasting with a 1% loss over the past four weeks [1][2]. Regulatory Update - The rise in CAPR shares is linked to a positive regulatory update regarding the Deramiocel program for Duchenne muscular dystrophy, following a Type A meeting with the FDA that provided guidance for a potential Biologics License Application [2]. Financial Expectations - The company is projected to report a quarterly loss of $0.54 per share, reflecting a year-over-year decline of 42.1%, while revenues are expected to reach $2.4 million, marking a 6.2% increase from the previous year [3]. Earnings Estimate Trends - The consensus EPS estimate for Capricor has remained stable over the last 30 days, indicating that stock price movements typically do not sustain upward trends without changes in earnings estimate revisions [4]. Industry Context - Capricor is part of the Zacks Medical - Products industry, where another company, biote Corp. (BTMD), experienced a 0.3% decline to $2.97, with a return of -11.3% over the past month [5].

FDA and Capricor aligned on endpoints for HOPE-3 pivotal trialHOPE-3 pivotal trial completed; topline data expected mid-Q4 2025 to support BLA resubmissionCompany preparing to resubmit CRL response under the current BLAConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced a regulatory update for ...

SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the first subjects have been dosed in a Phase 1 clinical trial evaluating its StealthX™ exosome- based vaccine. The study, funded by the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) under the U.S. Department of Health and Human Services' Project NextGen, ...

Core Insights - Capricor Therapeutics is focused on developing therapies for Duchenne cardiomyopathy and has faced regulatory challenges but is working on a clear path forward for approval [2][4] - The company has made significant progress with its exosome platform, StealthX™, which has received FDA clearance for clinical trials [4][6] - Financial results indicate a net loss for the second quarter of 2025, with revenues dropping to zero compared to the previous year [8][10] Corporate Update - Capricor aims to resubmit its Biologics License Application (BLA) for Deramiocel based on existing data, with additional data from the HOPE-3 trial expected in Q4 2025 [4][5] - The FDA has accepted all observations from the Pre-License Inspection, marking a milestone in regulatory progress [4][5] - The company is preparing for a Type A meeting with the FDA to discuss the approval pathway [4][5] Financial Performance - Cash position as of June 30, 2025, was approximately $122.8 million, down from $151.5 million at the end of 2024 [7][26] - Revenues for Q2 2025 were $0, a decrease from approximately $4.0 million in Q2 2024, and for the first half of 2025, revenues were also $0 compared to approximately $8.9 million in the first half of 2024 [8][10] - Total operating expenses for Q2 2025 were approximately $27.7 million, up from $15.6 million in Q2 2024 [9][10] Clinical Development - The HOPE-3 Phase 3 clinical trial is ongoing, with topline data expected in Q4 2025 [5][6] - The FDA has cleared the IND for the StealthX™ exosome-based vaccine, marking its first clinical entry [4][6] - Orphan Drug Designation has been granted for Deramiocel in Becker muscular dystrophy, expanding its therapeutic strategy [5][6]

Core Viewpoint - Capricor Therapeutics is advancing its lead cell therapy candidate, Deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) and has scheduled a Type A meeting with the FDA to discuss its regulatory path for the Biologics License Application (BLA) [1][4][7] Financial Results and Corporate Update - The release of Capricor's financial results for the second quarter ended June 30, 2025, has been rescheduled to August 11, 2025, after market close [2][3] - A conference call and webcast will be held on the same day at 4:30 p.m. ET to review the financial results and provide a corporate update [2][3] Company Overview - Capricor Therapeutics focuses on developing cell and exosome-based therapeutics for rare diseases, with Deramiocel being a key product candidate showing immunomodulatory and anti-fibrotic effects in muscular dystrophies [4] - The company is also utilizing its proprietary StealthX™ platform for preclinical development in areas such as vaccinology and targeted delivery of therapeutics [4] Commercialization Agreement - Capricor has entered into an exclusive agreement with Nippon Shinyaku Co., Ltd. for the commercialization and distribution of Deramiocel for DMD in the United States and Japan, pending regulatory approval [7]

Core Insights - Capricor Therapeutics is hosting a webinar on July 29, 2025, to discuss the status of its Biologics License Application (BLA) for Deramiocel and provide information on cardiomyopathy in Duchenne Muscular Dystrophy (DMD) [1][2] - Deramiocel is an allogeneic cardiac-derived cell therapy currently in late-stage development for DMD, demonstrating potent immunomodulatory and anti-fibrotic actions [3][5] - Capricor has entered an exclusive commercialization agreement for Deramiocel in the U.S. and Japan with Nippon Shinyaku Co., Ltd., pending regulatory approval [5] Company Overview - Capricor Therapeutics focuses on developing cell and exosome-based therapeutics for rare diseases, with a commitment to innovative treatments [3] - The company utilizes its proprietary StealthX™ platform for preclinical development in various therapeutic areas, including vaccinology and targeted delivery [3] Webinar Details - The webinar will include a review of the BLA status for Deramiocel and a Q&A session with the community [1] - A replay of the webinar will be available on the Parent Project Muscular Dystrophy (PPMD) website [2]

Core Insights - Capricor Therapeutics, Inc. is under investigation for potential claims related to its common stock following a significant stock price drop after receiving a Complete Response Letter from the FDA regarding its lead product candidate, Deramiocel [1][2]. Company Developments - Capricor is a clinical-stage drug company focused on developing Deramiocel for treating cardiomyopathy in patients with Duchenne muscular dystrophy [1]. - The company completed its Phase 2 HOPE-2 clinical trial in 2021 [1]. - On September 24, 2024, Capricor filed a Biologics License Application (BLA) with the FDA for Deramiocel, which led to a stock price increase from $5.97 to $9.10 per share [2]. - On May 13, 2025, Capricor reported no significant deficiencies following a mid-cycle review meeting with the FDA [2]. - On July 11, 2025, Capricor announced it received a Complete Response Letter from the FDA, stating that the BLA did not meet the requirements for substantial evidence of effectiveness and required additional clinical data, resulting in a stock price drop of 33% to $7.64 per share [2]. Investor Information - Investors who experienced losses in Capricor's common stock are encouraged to contact Wolf Popper LLP for discussions regarding the investigation [3].

Core Points - Holzer & Holzer, LLC is investigating Capricor Therapeutics, Inc. for potential compliance issues with federal securities laws following the receipt of a Complete Response Letter from the FDA regarding its Biologics License Application for Deramiocel [1] - The announcement of the CRL led to a decline in Capricor's stock price [1] Company Information - Capricor Therapeutics, Inc. trades on NASDAQ under the ticker CAPR [1] - Holzer & Holzer, LLC is a law firm that specializes in representing shareholders and investors in litigation, including class action and derivative litigation [3] - The firm has a history of recovering hundreds of millions of dollars for shareholders affected by corporate misconduct since its founding in 2000 [3]

Core Viewpoint - Capricor Therapeutics Inc. received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for Deramiocel, indicating that the application cannot be approved in its current form due to insufficient evidence of effectiveness and the need for additional clinical data [1][2]. Group 1: FDA Response and Requirements - The FDA stated that the BLA does not meet the statutory requirement for substantial evidence of effectiveness and that additional clinical data is needed [2]. - The CRL referenced outstanding items in the Chemistry, Manufacturing and Controls (CMC) section, which Capricor claims to have addressed in prior communications, but the FDA did not review these materials due to the timing of the CRL issuance [3]. Group 2: Next Steps and Company Plans - The FDA confirmed that it will restart the review clock upon resubmission and offered Capricor the opportunity to request a Type A meeting to discuss the path forward [4]. - Capricor plans to submit data from the Phase 3 HOPE-3 clinical trial to provide additional evidence of effectiveness, with topline results expected in the third quarter of 2025 [5]. Group 3: Market Reaction - Following the news, CAPR stock is down 37.4% at $7.14 during the premarket session [6].

Company Overview - Capricor Therapeutics (CAPR) shares increased by 20.4% to $9.25 in the last trading session, following a period of 25.1% loss over the past four weeks, indicating a significant recovery in stock performance [1] - The company is focused on developing Deramiocel, a cell therapy candidate aimed at treating Duchenne Muscular Dystrophy-associated cardiomyopathy [2] Regulatory Updates - Capricor provided positive regulatory updates regarding its Biologics License Application (BLA) for Deramiocel, with the FDA indicating that an Advisory Committee meeting is not required at this time [2] - The BLA is currently under Priority Review, with a target action date set for August 31, 2025, which may enhance investor confidence [2] Financial Performance Expectations - The company is expected to report a quarterly loss of $0.43 per share, reflecting a year-over-year decline of 22.9% [3] - Revenue projections for the upcoming quarter are estimated at $2.89 million, down 27.2% compared to the same quarter last year [3] Earnings Estimate Trends - The consensus EPS estimate for Capricor has remained unchanged over the last 30 days, suggesting stability in earnings expectations [4] - The stock's price movement is typically correlated with trends in earnings estimate revisions, indicating that future price strength may depend on any changes in these estimates [4] Industry Context - Capricor operates within the Zacks Medical - Products industry, which includes other companies such as Myomo, Inc. (MYO) [4] - Myomo's consensus EPS estimate has seen a significant change of -23.5% over the past month, indicating potential challenges within the same industry [5]